Edgewise Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported net income of $1,166.2 million ($10.71 basic, $9.65 diluted per share) for Q3 2026, compared to a net loss of $40.7 million ($0.39 per share) in Q3 2025.
• Recognized a gain on the sale of the sevasemten program of $1,348 million in Q3 2026, compared to $0 in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $1,743.9 million as of September 30, 2026, up from $530.1 million as of December 31, 2025.
• Research and development expenses were $31.6 million in Q3 2026, a decrease from $37.5 million in Q3 2025, driven by lower costs following the sevasemten sale, partially offset by increased spend on EDG-7500 and personnel.
• General and administrative expenses were $14.6 million in Q3 2026, an increase from $9.4 million in Q3 2025, due to higher personnel-related costs (including stock-based compensation), professional fees, and administrative costs.
• Total operating expenses were $46.1 million in Q3 2026 compared to $46.9 million in Q3 2025.
• Interest income was $16.5 million in Q3 2026, compared to $6.2 million in Q3 2025.
• Income tax expense was $155.3 million in Q3 2026, compared to $0 in Q3 2025.
• Total assets were $1,780.0 million as of September 30, 2026, compared to $552.6 million as of December 31, 2025.
• Total liabilities were $147.4 million as of September 30, 2026, compared to $30.3 million as of December 31, 2025.
• Stockholders' equity was $1,632.7 million as of September 30, 2026, compared to $522.3 million as of December 31, 2025.

Guidance and Future Outlook:

• Expects to initiate the Phase 3 trial for EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) by the end of 2026.

Business Segments and Product Lines:

• EDG-7500 (HCM): Published preclinical pharmacologic profile in JCI Insight demonstrating the drug's mechanism targeting the regulatory light chain to improve cardiac relaxation while preserving systolic performance. Positive top-line results from the 12-week Phase 2 Part D CIRRUS-HCM open-label trial were presented at the European Society of Cardiology Congress in August 2026.
• EDG-15400 (HFpEF): Dosed the first patient in the Phase 2 EQUINOX-HFpEF trial evaluating the drug in adults with symptomatic heart failure with preserved ejection fraction (HFpEF) and a left ventricular ejection fraction of at least 50%.
• Sevasemten Sale: Completed the sale of the sevasemten program and muscular dystrophy business to Servier in July 2026, receiving $1,396 million in upfront cash proceeds at closing.

Market and Competitive Landscape:

• The company operates as a clinical-stage cardiovascular biopharmaceutical company developing novel therapies to address cardiac equilibrium.
• The press release does not provide specific market share data, competitor names, or detailed market trend analysis beyond the context of the company's specific programs.

Risks and Challenges:

• Risks include the potential for product candidates to fail to demonstrate safety and efficacy, cause serious adverse events, or fail to receive regulatory approval.
• The company faces risks related to its limited operating history, lack of commercial revenue to date, and substantial dependence on the success of EDG-7500.
• Potential risks include the need for additional capital, failure to achieve market acceptance, delays in clinical trial enrollment, and risks associated with the sevasemten transaction (e.g., failure to receive escrowed amounts or milestone payments).
• Forward-looking statements are subject to uncertainties regarding clinical trial results, regulatory processes, and general economic conditions.

Management Commentary and Tone:

• Kevin Koch, Ph.D., President and CEO, stated that the third quarter reflected "continued execution across both cardiovascular programs."
• Management highlighted that positive CIRRUS-HCM Part D results and the JCI Insight publication reinforce the differentiated profile of EDG-7500.
• Management noted the successful initiation of the EQUINOX-HFpEF trial for EDG-15400.

Other Key Points:

• The significant financial turnaround from a net loss to a net income of over $1.1 billion was primarily driven by the one-time gain from the sevasemten sale to Servier.
• The company received $1,396 million in upfront cash proceeds from the Servier transaction.
• The CIRRUS-HCM trial data was presented as a late-breaking science presentation at the European Society of Cardiology Congress.
• The EQUINOX-HFpEF trial is registered on ClinicalTrials.gov (NCT07795814).